My last blog raised issues about the involvement of Shire Pharmaceuticals in lobbying for the inclusion of mandatory screening of children for ADHD in a bill before the UK parliament. It questioned the involvement of key opinion leaders including MEP Nessa Childers and their failure to disclose their links with Shire.
Two days after my last blog post was published I received an email in response to one I had sent to Irish politician and Member of the European Parliament, Nessa Childers two weeks before. The email reads
Dear Maria Bradshaw
Thank you for your email dated 30th January regarding the Launch of a European White Paper on Attention-Deficit Hyperactivity Disorder (ADHD). This event was held in the Radisson EU Hotel, Brussels on the 23 April 2013, and co-chaired by myself and Marian Harkin MEP, and discussed the issue of ADHD from a number of perspectives. My interest in the research arose from a professional involvement with ADHD, as I worked with adult sufferers.
You ask if I was aware that the event and the research was funded by Shire Pharmaceuticals, and yes Shire Pharmaceutical’s involvement and support was clearly identified by the researchers who wrote the white paper; and in the invitation to the event organized to launch the research. As you are probably aware, patient groups are often funded and supported by pharmaceutical companies.
As co-chair of the European Parliament’s Mental Health Interest Group, I also regularly host roundtable meetings which by their definition involve all stakeholders, including patient groups, medical professionals, and pharmaceutical companies.
The purpose of the white paper in question was to increase public awareness of ADHD. On the day we launched policy solutions to address the societal impact, costs and long-term outcomes in support of individuals affected by ADHD. The white paper recommended the need to raise informed awareness of ADHD, and the need to improve access to early and accurate diagnosis. The paper also identified the need to improve access to treatment and care, and greater support for patient organisations and encouraged a patient-centred research agenda.
Your concern, outlined in your email, is that we must avoid a medicalised approach to ADHD, and can I state in the most strident terms that I am in no way a proponent of any pharmaceutical company, and never have been. I have over twenty years’ experience as a mental health professional. At no stage either as a practicing psychotherapist or in my role as a member of the European Parliament’s Environment and Public Health Committee have I ever recommended the prescription of drugs. As a professional therapist, I couldn’t prescript or promote medication, however I did have a duty of care in an emergency situation to ensure that a client sought medical support.
In my work in the European Parliament as an MEP, my policy has always been to promote a non-medicalised approach to mental health. Last year I hosted a major conference in Limerick on this very subject. However as a politician with an interest in public health, I see value in meeting people with a different perspective and to present my point of view. But in my legislative role I support and call for full independent analysis of new policy proposals. In that perspective I fully agree with you.
I noticed in your article published by madinamerica.com that you are based in Cork and perhaps at some stage we might be able to meet to discuss the issue of ADHD further.
Nessa Childers MEP
I appreciate the response from Ms Childers but I have an issue with the notion that the White Paper funded by Shire and endorsed by Ms Childers was developed to raise awareness of ADHD. I also have an issue with the notion that the Roundtable meeting that preceded the writing of the paper was a meeting of a range of interest groups.
There are two commonly accepted definitions of a White Paper. The first is a government document which sets out a policy direction, the second is a marketing document designed to influence opinion and generate sales. In the business community in which Shire operates, White Papers are a content marketing tool designed not to inform but to persuade. The White Paper endorsed by Ms Childers is very clearly of the latter variety.
The disclosure statement at the end of Shire’s paper tells us two things critical to understanding its purpose. The first, that the paper was ghostwritten, is hardly a revelation -this practice is almost standard practice in the pharmaceutical industry -but this fact, along with the statement that the content of the paper was reviewed by Shire, should have given Ms Childers cause to consider that the paper rather than reflecting the views of the named authors, reflects a set of messages developed by Shire. Much more of a red flag however is the disclosure that Shire employed APCO Worldwide to assist with the development of the paper. Surely Ms Childers would have informed herself that APCO is a company that assists industry to develop strategy for influencing government policy.
APCO’s involvement tells us that while Nessa Childers may believe she chose to involve herself in this project it is far more likely that her name was on a strategy document produced by APCO for Shire when the project was at the conceptual stage and well before she was aware of its existence. Just as it is likely all the roundtable participants were handpicked and the perspectives presented on ADHD carefully controlled. A small amount of research into those who participated in the roundtable and contributed to the White Paper reveals their strong financial links with Shire.
APCO’s website provides case studies which show how it assists companies like Shire to influence government policy and the views and behavior of politicians, professionals and consumers. The company has an impressive list of consultants available to assist pharmaceutical companies to develop strategy to influence government policy. They include former elected leaders, ambassadors and government officials and academics at leading universities. Individuals on their general and health advisory committees include people who in previous roles were Tony Blair’s Chief of Staff, special assistant to President Barack Obama for health care and economic policy, director of policy for the White House Office of Public Engagement and Intergovernmental Affairs; deputy secretary of the U.S. Department of Health and Human Services for President George W. Bush and a range of other influential positions.
APCO’s case study on a project they conducted for Merck Sharp & Dohme (MSD) is illuminating. MSD approached APCO after the FDA issued a public notice issued reporting 28 cases of a rare but potentially fatal bowel condition, intussusception, that appeared in babies after they had received the MSD Rotavirus vaccine. The FDA notice and media reports caused the public, doctors and parents with babies to become concerned about the safety of the vaccine, particularly in the Asia Pacific region.
APCO, worked with MSD to develop a public relations campaign in the region which involved 2 leading pediatricians delivering APCO developed key messages and highlighting a report which concluded that the vaccine did not increase the chance of intussusception in babies. The result according to APCO’s website was that
APCO’s media campaign generated widespread, positive coverage of MSD’s key messages. As a result, public confidence in the vaccine was swiftly restored.
So successful was APCO’s campaign that the New Zealand government added Rotorvirus to its National Immunisation Schedule.
APCO’s website details how it worked with America’s pharmaceutical companies to launch the Partnership for Prescription Assistance (PPA) and initiative to help uninsured or underinsured patients access programmes which provide prescription medicine for free. The campaign objectives included boosting enrollment in public and private drug provision programs. The results included the recruitment of more than 1,300 partner organizations, including the American Academy of Family Physicians, Easter Seals, National Alliance for Hispanic Health, National Urban League, NAACP and United Way of America, the generation of more than 7,000 positive and on-message media clips in print, broadcast and online outlets across the country and within 18 months, having connected over 2.5 million patients with programmes that provided them with free prescription drugs.
When the Immunex Corporation wanted to launch a new drug for multiple sclerosis, APCO tells us it
launched a patient outreach and education program; an online initiative designed to both inform and interact with patients and caregivers; a medical professional spokesperson network; and a collaborative effort with the company's marketing officials to place high-profile stories on television and radio and in newspapers and online media. In addition, APCO collaborated with officials of the company to contribute to the successful clinical and regulatory strategy designed to help guide the drug successfully toward FDA approval and launch
APCO states that
Once the FDA issued its approval of Novantrone, public relations, public affairs and media relations tactics were ready at the flick of a switch. Influential patient-focused media and Internet coverage of the approval resulted. The additional revenue and positive results contributed significantly to the shareholder value of Immunex and became an important asset related to the eventual sale of the company to Amgen Corporation.1
How likely is it then that as part of the strategy APCO developed for Shire, who have been very explicit about their goal to increase revenues by increasing the rate of diagnosis and treatment of ADHD in Europe, APCO assisted Shire to establish a roundtable meeting, publish a White Paper, engage key opinion leaders like Ms Childers to promote that paper and establish a group of medical professionals to lobby government for mandatory ADHD screening for children excluded from school. Pretty damn likely if you ask me. The establishment of the Better Futures Group/UKAP, a large number of Shire funded ADHD patient groups in Europe, the development of ADHD patient and teacher resources and the use of UKAP to lobby government are also likely to have been part of this strategy.
As a precursor to writing the White Paper, Shire funded a meeting described in the document as ‘a European Expert Roundtable on ADHD’ which involved clinicians, patients’ and families’ advocacy groups and representatives from the education and criminal justice systems.’
Ms Childers references this meeting when she states ‘the fact that this Expert White Paper was endorsed by a variety of stakeholders makes the messages it contains even stronger.’
In fact 18 of the 21 participants in the roundtable meeting have financial links to Shire. The remaining three are representatives of organisations supported by and influential with the European Commission who are responsible for the development of European Regulations.
The Roundtable members and their links with Shire are listed below
Phil Anderson is a member of the Professional Advisory Board for ADDISS which receives Shire funding. Phil Anderson’s book on ADHD was published by ADDISS. ADDISS participated in Shire’s European Caregiver Survey.
Alistair Benbow is Executive Director of the European Brain Council who receive funding from Shire.
Kate Carr-Fanning is Vice President of HADD and member of a steering committee for who receives meeting fees from shire which she donates to HADD.
NOTE: Following publication of this blog, the webpage for the Alliance for Change was amended to say that Kate Carr-Fanning has not received any payment from Shire for her involvement on the Steering Committee. At the time of writing the blog however it said that the fees received had been donated to HADD.
Stephanie Clark represents Aandacht Adult ADHD Support Groups, Belgium which is a member of ADHD-Europe who collaborated with Shire on the production of the ADHD Partnership Support Pack.
Professor Marina Dankaerts received research grants from Shire Pharmaceuticals to conduct research on ADHD between 2008 and 2011.
Dolores Gauci was president of GAMIAN, to whom Shire donates funds, when Shire was accepted as a corporate member.
Fiona McNicholas is on Shire’s advisory board and has received honoraria and travel support from Shire. She also receives payment from Shire as a member of the steering committee of Shire funded ADHD Alliance for Change.
Fulgencio Madrid Conesa is president of Spanish Federation of ADHD Supporting Associations (FEAADAH) which is a member of ADHD Europe who collaborated with Shire to produce the ADHD Partnership Support Pack. He is also a paid member of the steering committee of Shire funded ADHD Alliance for Change.
Myriam Menter is CEO of ADHS Deutschland, Germany participated in the Shire funded European Caregiver Survey and President of ADHD-Europe who collaborated with Shire on the provision of the ADHD Partnership Support Pack and conducted the European Caregiver Survey with Shire.
Pedro Montellano is president of Gamian-Europe which receives funding from shire and was part of the partnership with Shire and the European Brain Council which developed the White Paper.
Joanne Norris represents ADHD-ASC-LD Family Resources, Belgium, a former vice president. ADHD Europe which collaborated with Shire on the provision of the ADHD Partnership Support Pack. She received payment from Shire as a member of the steering committee for the ADHD Alliance which she donated to ADHD, ASC & LD Resources Belgium.
Javier Quintero has collaborated with Shire employees on ADHD research, received research funding and been a member of the Shire speakers bureau.
Prof Gil Zalsman is President of the European Pyschiatric Association which receives Shire funding and member of the scientific advisory committee and presenter at the meeting of ADHD Worldwide an organisation comprising Shire funded UKAAN, the European Network for Adult ADHD established by Sandra Kooij who receives Shire funding and Shire funded ASPARD.
In addition to being the named authors of the White Paper and members of the Roundtable, Susan Young, Michael Fitzgerald and Maarten Postma were paid by Shire to present to the Roundtable members. All have received research funding, grants or honoraria from Shire.
I am not questioning the commitment Ms Childers has to improving the lives of children. I have no reason to believe she is anything but sincere in her commitment to child welfare. What I am questioning is her vigilance in ensuring she is not being used by Shire Pharmaceuticals to promote drug sales rather than promote child well-being.
As a clinician, Ms Childers is no doubt aware that in comparison to short term studies, very few studies of children medicated for ADHD have looked at long term outcomes on the objectives the White Paper and the UKAP purport to concern themselves with – educational achievement and improved relationships with others. Those studies which have however, have found no or little benefit from medication over the long term. A recent large longitudinal study in Quebec found that reducing the cost of ADHD medication resulted in increases in the numbers of children being medicated and that over the long term, the authors found
the increase in medication use among children with ADHD is associated with increases in the probability of grade repetition, lower math scores, and a deterioration in relationships with parents. When we turn to an examination of long-term outcomes, we find that increases in medication use are associated with increases in the probability that a child has ever suffered from depression and decreases in the probability of post secondary education among girls.
Even in studies that have found benefits to children of taking ADHD drugs, those benefits are very small and do not outweigh the risks acknowledged by Shire of sudden death, increased blood pressure, cardiomyopathy, aggressive behaviour or hostility, impaired growth, blurred vision, seizures, hallucinations, delusional thinking and mania.
As the New York Times points out in an article which examines Shire’s marketing of ADHD drugs,
The rise of A.D.H.D. diagnoses and prescriptions for stimulants over the years coincided with a remarkably successful two-decade campaign by pharmaceutical companies to publicize the syndrome and promote the pills to doctors, educators and parents. Behind that growth has been drug company marketing that has stretched the image of classic A.D.H.D. to include relatively normal behavior like carelessness and impatience, and has often overstated the pills’ benefits. 
The article points out that Patient advocacy groups tried to get the government to loosen regulation of stimulants while having sizable portions of their operating budgets covered by pharmaceutical interests.5
It goes on to describe how
Many studies, often sponsored by pharmaceutical companies, have determined that untreated A.D.H.D. was associated with later-life problems. But no science determined that stimulant treatment has the overarching benefits suggested in those ads, the F.D.A. has pointed out in numerous warning letters to manufacturers since 2000. Shire agreed last February to pay $57.5 million in fines to resolve allegations of improper sales and advertising of several drugs, including Vyvanse, Adderall XR and Daytrana, a patch that delivers stimulant medication through the skin. 5
A 1995 documentary on PBS detailed how patient advocacy group Chadd failed to disclose its relationship with drug companies to either the Drug Enforcement Administration, which it was then lobbying to ease government regulation of stimulants, or the Department of Education, with which it collaborated on an A.D.H.D. educational video. Does Nessa Childers not consider that the Shire funded UKAP/Better Futures Group who are lobbying the government for mandatory screening of children for ADHD should similarly disclose its ties to Shire Pharmaceuticals? Given she is one of the few politicians who knows of those links does she not think she has an obligation to raise this issue with Susan Young, president of the UKAP, paid Shire consultant and author of the white paper when she and Susan are having publicity photos taken together?
Prescriptions for ADHD drugs have increased over 60% in Ireland and 56% in the UK, in the last 6 years. The recently released report into Irish CAHMS services shows 31% of children referred to mental health services are referred for treatment for ADHD.
A Danish study published last year showed that between 2003 to 2010, the prescribing of ADHD drugs for children aged 6-13 years with ADHD increased six-fold, and with ASD and other psychiatric disorders increased five-fold. Another Danish study showed “users of ADHD drugs across all age categories had an increased use of drugs related to the nervous system, especially antipsychotics.”
In a recent Shire newsletter, the company’s European Head of Government Relations and Public Affairs Emmanuel Chantelot says in relation to the White Paper “With such a strong, evidence-based report, we have come a long way to meet the goal of raising awareness of ADHD as a serious condition, together with our partners. We’ve also forged some very important partnerships with the European Brain Council and GAMIAN-Europe (Global Alliance of Mental Illness Advocacy Networks-Europe) that have adopted the policy recommendations as their own and are promoting them among their own member networks.
Ms Childers is elected to represent the interests of her constituents, not of Shire Pharmaceuticals. In my view it behoves her to be more vigilant about the motives and strategies of those she works with in the mental health field and to ensure her good intentions are not being manipulated for commercial gain.
I will be writing to Ms Childers to accept her offer to meet and hope that she will experience some benefits in meeting with consumer groups with no pharmaceutical company links and will work to ensure that such representation is present in any mental health policy formulation group she endorses in future.
A review of recent studies on long term effects of ADHD drugs can be found at http://www.nature.com/news/medication-the-smart-pill-oversell-1.14701
 Janet Currie, Mark Stabile, Lauren E. Jones Nber Working Paper Series Do Stimulant Medications Improve Educational And Behavioral Outcomes For Children With Adhd? Working Paper 19105 National Bureau Of Economic Research 1050 Massachusetts Avenue Cambridge, Ma 02138 http://papers.nber.org/tmp/55821-w19105.pdf
 The Merrow Report ADD A Dubious Diagnosis? http://www.pbs.org/merrow/repository/Television/Past/_attn/guide.html
 Dalsgaard S, Nielsen HS, Simonsen M. J Child Adolesc Psychopharmacol. 2013 Sep;23(7):432-9. Epub 2013 Sep 9. Five-fold increase in national prevalence rates of attention-deficit/hyperactivity disorder medications for children and adolescents with autism spectrum disorder, attention-deficit/hyperactivity disorder, and other psychiatric disorders: a Danish register-based study.
 Pottegård A, Bjerregaard BK, Glintborg D, Kortegaard LS, Hallas J, Moreno SI. The use of medication against attention deficit/hyperactivity disorder in Denmark: a drug use study from a patient perspective. Eur J Clin Pharmacol. 2013 Mar;69(3):589-98. doi: 10.1007/s00228-012-1344-0. Epub 2012 Jul 19.
 Responsibility Matters—Shire Issue 4—September 2013 http://www.shire.com/shireplc/uploads/highlight/ShireResponsibilityMattersSeptember2013.pdf